Alnylam's Onpattro To Be Reviewed By FDA Panel In September

(RTTNews) - Alnylam Pharmaceuticals Inc.'s (ALNY) supplemental New Drug Application for ONPATTRO in the expanded indication of cardiomyopathy of ATTR amyloidosis is scheduled to be reviewed by an FDA panel on September 13, 2023.

Transthyretin-mediated (ATTR) amyloidosis is a rare, rapidly progressive, debilitating disease caused by misfolded transthyretin (TTR) proteins which accumulate as amyloid fibrils in multiple tissues including the nerves, heart, and gastrointestinal tract.

The FDA's final decision on ONPATTRO for the above proposed expanded indication is expected on October 8, 2023. The U.S. regulatory agency usually follows the recommendations of its panels although it is not mandatory to do so.

ONPATTRO, known generically as Patisiran, is already approved in the U.S. for the treatment of polyneuropathy caused by hereditary transthyretin-mediated amyloidosis. The drug generated global annual revenue of $558 million in 2022.

Currently, shares of Alnylam are trading at $195.24 up 2.19% or $4.18 on Nasdaq.